Safety and Efficacy of Gabapentin in Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712439
• Other study ID #: 81-0046
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2008
• Last updated: June 6, 2011
• Start date: April 2006
• Est. completion date: December 2006

Study information

• Verified date: June 2011
• Source: Depomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a new Gabapentin tablet, is safe and effective for the treatment of painful diabetic peripheral neuropathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women 18 years or older with diagnosis of type 1 or type 2 diabetes who have reported symmetrical painful symptoms in distal extremities for 1-5 years prior to the study and whose symptoms are attributable to sensorimotor diabetic peripheral neuropathy (DPN).

• Patients of childbearing potential must have a negative urine pregnancy test at screening/randomization, and must use medically acceptable methods of birth control.

• Patient has pain score of at least 4 on the 11-point Likert numerical rating scale at screening. Potential patients should not be informed of the pain intensity eligibility criterion prior to screening or randomization.

• Patient has a mean baseline week pain intensity of at least 4 on the 11-point Likert scale at the end of a one-week pre-treatment period and has completed at least 4 days of diary entries during the baseline week.

• Patient is on stable regimen of antidiabetes medication at screening that can be maintained during the study.

• Patient has hemoglobin A1c (HbA1c) =11% at screening.

• Patient has FPG =310 mg/dL at screening.

• Patient must have a minimum washout of greater than 5 times the half-life of the drug of any of several medications

• Patients currently treated with gabapentin or pregabalin at screening may be eligible for the study, but must have tapering period wherein the dose of gabapentin is reduced gradually over a period of at least 7 days plus a 2-day or 3-day washout of gabapentin or pregabalin, respectively, prior to start of the Baseline Week.

• Patient must have adequate eyesight to complete questions on the DiaryPro and SitePro. If a patient is unable to do so (for reasons other than severe eye disease) but a caregiver is available to complete these tasks following instruction from the patient, the caregiver may be trained to accomplish these tasks

Exclusion Criteria:

• Patients who have previously not responded to treatment for DPN with gabapentin at doses of =1200 mg/day or pregabalin at doses =300 mg/day.

• Patients who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.

• Patient has hypersensitivity to gabapentin.

• Patient is a nursing mother.

• Patient has used injected anesthetics or steroids within 30 days of baseline.

• Patient has certain conditions that could confound evaluation of painful DPN, in particular, amputations other than toes, non-diabetic neurologic disorders (e.g. phantom limb pain), and skin conditions affecting sensation in painful limbs.

• Patient has skin conditions in the area affected by the neuropathy that could alter sensation.

• Patient is in an immunocompromised state.

• Patient has an estimated creatinine clearance of <60 ml/min calculated using the Cockroft Gault method (Appendix 3).

• Patient has had malignancy within past 2 years other than basal cell carcinoma.

• Patient has had gastric reduction surgery.

• Patient has severe chronic diarrhea, chronic constipation [unless attributed to drugs that will be washed out], uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.

• Patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant.

• Patient has a history of substance abuse within the past year.

• Patient has had 1 or more visits to an emergency room or hospital within the previous 30 days due to hypoglycemia.

• Patient has a history of seizure (except for infantile febrile seizure) or is at risk of seizure due to head trauma.

• Patient has a history of pernicious anemia, untreated hypothyroidism, chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.

• Patient has any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.

• Continuing use of any concomitant medication excluded by Inclusion Criterion 8.

• Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• Gabapentin Extended Release tablets

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Depomed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the mean daily pain score from the baseline week to end of efficacy treatment period (Treatment Week 4) in patients with DPN.		4 weeks	No
Secondary	Secondary efficacy measures will include changes from baseline in average daily sleep interference scores, SF-MPQ, BPI,NPS, PGIC, and CGIC.		4 weeks	No